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Diabetic Ketoacidosis in Patients with Diabetes: Clinical trial and postmarketing cases of diabetic ketoacidosis (DKA), a serious life threatening condition requiring urgent hospitalization, have been reported in patients with type 2 diabetes mellitus treated with dapagliflozin and other sodium-glucose co-transporter 2 (SGLT2) inhibitors. A number of these cases have been atypical with blood glucose values below 13.9 mmol/L (250 mg/dL). Some cases of DKA have been fatal.
Patients should be assessed for DKA immediately if non-specific symptoms such as difficulty breathing, nausea, vomiting, abdominal pain, confusion, anorexia, excessive thirst and unusual fatigue or sleepiness occur, regardless of blood glucose level. If DKA is suspected or diagnosed, dapagliflozin should be discontinued immediately.
Dapagliflozin should not be used for the treatment of DKA or in patients with a history of DKA.
Dapagliflozin is not indicated, and should not be used, in patients with type 1 diabetes.
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